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70% Covid patients on Favipiravir trial have improved: Glenmark

The open label, randomized and multicenter clinical trial, conducted on 150 patients across seven hospitals, evaluated the efficacy and safety of Favipiravir and its standard supportive care (Favipiravir treatment arm), when compared to standard supportive care alone (control arm). All the patients had mild to moderate symptoms and had tested positive within a 48-hour window by RT-PCR.

MUMBAI: Glenmark Pharmaceuticals announced on Wednesday that phase three of the Favipiravir clinical trials has demonstrated a marked improvement in curing mild-to-moderate Covid infections, with 70% patients reportedly achieving clinical cure.

The open label, randomized and multicenter clinical trial, conducted on 150 patients across seven hospitals, evaluated the efficacy and safety of Favipiravir and its standard supportive care (Favipiravir treatment arm), when compared to standard supportive care alone (control arm). All the patients had mild to moderate symptoms and had tested positive within a 48-hour window by RT-PCR.

Around 70% of the patients in the Favipiravir treatment arm achieved clinical cure by the fourth day, which was statistically significant when compared to 44.9%, observed in the control arm, a company statement says.

Results from the phase three trial showed numerical improvements in the primary efficacy endpoint, with 28.6% faster viral clearance in the overall population as measured by the median time until cessation of oral shedding of virus in the Favipiravir treatment arm. Patients in the Glenmark Favipiravir clinical trial received Favipiravir tablets of 3,600 mg (1,800 mg twice a day- on day 1) and 1,600 mg (800 mg twice a day on day 2 or later) for up to 14 days, along with the standard supportive care.

The most commonly observed side-effect was increased uric acid (12 patients in the Favipiravir treatment arm and zero in the control arm), but most resolved on the first follow up.

Glenmark defended the pricing of its Covid-19 drug, FabiFlu (Favipiravir), on July 21, saying that it’s lower when compared to other countries. In a response to the Drugs Controller General of India seeking clarification on the pricing of the “Covid-19 drug”, the company said both clinical trials and restricted use approval were preceded by multiple dialogues, deliberations and consideration before a subject expert committee constituted by the ministry of health and family welfare.

The company plans to submit the clinical trial data for publication in a peer-reviewed journal in the coming weeks.